Laparoscopic instrument and trocar systems and related surgical method

ABSTRACT

Laparoscopic instruments and trocars are provided for performing laparoscopic procedures entirely through the umbilicus. A generally C-shaped trocar provides increased work space between the hands of the surgeon as well as S-shaped laparoscopic instruments placed through the trocar when laparoscopic instrument-trocar units are placed through the umbilicus. In order to facilitate retraction of intra-abdominal structures during a laparoscopic procedure, an angulated needle and thread with either one- or two sharp ends is provided. Alternatively, an inflatable unit having at least one generally C-shaped trocar incorporated within the unit&#39;s walls can be placed through the umbilicus following a single incision. Generally S-shaped laparoscopic instruments may be placed through the generally C-shaped trocars to facilitate access to intra-abdominal structures.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of application Ser. No. 13/835,850,filed on Mar. 15, 2013, now U.S. Pat. No. 9,011,474, which is acontinuation of application Ser. No. 11/904,263 filed Sep. 26, 2007, nowU.S. Pat. No. 8,562,641, which is a divisional of application Ser. No.10/253,244 filed Sep. 24, 2002, now U.S. Pat. No. 7,344,547, which is acontinuation in part of application Ser. No. 09/397,630 filed Sep. 15,1999, now U.S. Pat. No. 6,454,783, which claims the benefit of priorityto U.S. Provisional Patent Application No. 60/100,823 filed Sep. 15,1998. The entire contents of each of the aforementioned applications arehereby incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to surgical instruments, and particularlyto laparoscopic instruments, which facilitate the performance oflaparoscopic procedures entirely through the umbilicus.

BACKGROUND INFORMATION

Abdominal laparoscopic surgery gained popularity in the late 1980's,when benefits of laparoscopic removal of the gallbladder overtraditional (open) operation became evident. Reduced postoperativerecovery time, markedly decreased post-operative pain and woundinfection, and improved cosmetic outcome are well established benefitsof laparoscopic surgery, derived mainly from the ability of laparoscopicsurgeons to perform an operation utilizing smaller incisions of the bodycavity wall.

Laparoscopic procedures generally involve insufflation of the abdominalcavity with CO₂ gas to a pressure of around 15 mm Hg. The abdominal wallis pierced and a 5-10 mm in diameter straight tubular cannula or trocarsleeve is then inserted into the abdominal cavity. A laparoscopictelescope connected to an operating room monitor is used to visualizethe operative field, and is placed through (one of) the trocarsleeve(s).

Laparoscopic instruments (graspers, dissectors, scissors, retractors,etc.) are placed through two or more additional trocar sleeves for themanipulations by the surgeon and surgical assistant(s).

Recently, so-called “mini-laparoscopy” has been introduced utilizing 2-3mm diameter straight trocar sleeves and laparoscopic instruments. Whensuccessful, mini-laparoscopy allows further reduction of abdominal walltrauma and improved cosmesis. However, instruments used formini-laparoscopic procedures are generally more expensive and fragile.Because of their performance limitations, due to their smaller diameter(weak suction-irrigation system, poor durability, decreased videoquality), mini-laparoscopic instruments can generally be used only onselected patients with favorable anatomy (thin cavity wall, fewadhesions, minimal inflammation, etc.). These patients represent a smallpercentage of patients requiring laparoscopic procedure. In addition,smaller, 2-3 mm, incisions may still cause undesirable cosmetic outcomesand wound complications (bleeding, infection, pain, keloid formation,etc.).

Since the benefits of smaller and fewer body cavity incisions areproven, it would be attractive to perform an operation utilizing only asingle incision in the navel. An umbilicus is the thinnest and leastvascularized, and a well-hidden, area of the abdominal wall. Theumbilicus is generally a preferred choice of abdominal cavity entry inlaparoscopic procedures. An umbilical incision can be easily enlarged(in order to eviscerate a larger specimen) without significantlycompromising cosmesis and without increasing the chances of woundcomplications. The placement of two or more standard (straight) cannulasand laparoscopic instruments in the umbilicus, next to each other,creates a so-called “chopstick” effect, which describes interferencebetween the surgeon's hands, between the surgeon's hands and theinstruments, and between the instruments. This interference greatlyreduces the surgeon's ability to perform a described procedure.

Thus, there is a need for instruments and trocar systems, which allowlaparoscopic procedures to be performed entirely through the umbilicuswhile at the same time reducing or eliminating the “chopstick effect”. Alaparoscopic procedure performed entirely through the umbilicus, usingthe laparoscopic instruments and trocar system according to anembodiment of the present invention, allows one to accomplish thenecessary diagnostic and therapeutic tasks while further minimizingabdominal wall trauma and improving cosmesis.

SUMMARY OF THE INVENTION

The present invention provides laparoscopic instruments and trocarsleeves for the performance of laparoscopic procedures, for instance,entirely through the umbilicus.

An object of the present invention is to provide a laparoscopicinstrument-trocar unit, which markedly increases the workspace betweenthe hands of the surgeon when the laparoscopic instrument-trocar unitsare placed through the umbilicus.

An additional object of the present invention is to provide a generallyC-shaped trocar sleeve or laparoscopic cannula, which facilitatesreduction in the interference between manipulated laparoscopicinstruments.

Another object of the present invention is to provide generally S-shapedlaparoscopic instruments, where the proximal curve of “S” corresponds tothe “C” curve of the C-shaped trocar sleeve or cannula creatingseparation between manually controlled ends of the laparoscopicinstruments, while the distal curve of the “S” creates a markedlyincreased work space between laparoscopic instruments.

Another object of the present invention is to provide a stretchable andinflatable generally C-shaped trocar sleeve or cannula for accommodationof the rigid generally S-shaped laparoscopic instruments, which, wheninflated creates a single unit with an S-shaped instrument.

Another object of the present invention is to provide an inflatable unitwith at least one generally C-shaped trocar sleeve or cannulaincorporated within the unit's walls, which can be placed through theumbilicus following a single incision.

Another object of the invention is to provide an angulated needle withtwo sharp ends and a thread attached to the angle of the needle for usein organ retraction, which allows penetration of the abdominal wall, anintra-abdominal structure, and then the abdominal wall again without achange in the orientation of the needle.

A further object of the present invention is to provide an angulatedneedle having a long segment on one side of the angle, which terminatesin a sharp point and a shorter segment on the other side of the angle,which has a thread, attached to it.

A surgical assembly includes, in accordance with the present invention,a trocar sleeve or cannula and an elongate instrument having at leastone preformed inherently C-shaped section. The trocar sleeve or cannulais flexible, while the C-shaped section of the elongate instrument issufficiently rigid so that the trocar sleeve or cannula bends to conformto the shape of the C-shaped section upon an insertion of the elongateinstrument through the trocar sleeve or cannula so that the C-shapedsection at least partially traverses the same.

The C-shaped section may be one of two C-shaped sections of theinstrument, both of the C-shaped sections being preformed. Where the twoC-shaped sections are disposed in a common plane, face in opposingdirections and are at least substantially contiguous with one another,the instrument has an S-shaped form. Both C-shaped sections may besubstantially rigid. Alternatively, one of the C-shaped sections may theflexible while the other is substantially rigid.

A cannula assembly in accordance with the present invention comprises aplurality of cannulas and a cannula holder. The cannula holder in turncomprises an upper surface, a lower surface disposed below the uppersurface, and an outer wall connected between the upper surface and thelower surface. A chamber is enclosed within the upper surface, the lowersurface and the outer wall. The cannulas are disposed through the uppersurface and the lower surface of the holder. At least one of thecannulas is a flexible cannula or an arcuate cannula that is concave onone outer side and convex on an opposite outer side.

Pursuant to additional features of the present invention, at least agiven one of the cannulas is spaced from the outer wall and is coupledto the outer wall of the cannula holder via a connector such as atubular member parallel to the outer wall of the holder.

Preferably, the cannula holder is an inflatable unit. Alternatively, thecannula holder is substantially rigid or semirigid.

Optionally, at least one of the cannulas is disposed within the outerwall of the cannula holder. As a group, the cannulas may have variouscombinations of shapes and degrees of rigidity. For instance, one ormore of the cannulas may be straight and rigid, or curved and rigid,while other cannulas may be straight in a relaxed or nonstressedconfiguration and flexible so as to bend into a curved configurationupon insertion of an instrument having a curved section with a higherdegree of rigidity.

The holder may be formed with at least one passageway extending from theupper surface to the lower surface for the reception of one of theelongate instruments. The passageway communicates with the ambientenvironment and is accordingly disposed outside of the chamber in thecannula holder. The passageway is preferably, but not necessarily,defined by a flexible cylindrical web so that the passageway is closedupon inflation of the cannula holder. During insertion of a cannula intothe passageway, the cannula presses the web apart and forms a gas-tightseal therewith.

The cannula holder may have pre-attached cannulas or be free of attachedcannulas but have several air-tight openings (passageways), which canaccommodate as many different cannulas as needed during a laparoscopicprocedure.

An additional cannula may be disposed outside of the holder chamber andspaced from the holder outer wall, the additional connector beingconnected to the cannula holder.

A surgical method comprises, in accordance with a particular embodimentof the present invention, forming an opening in a patient, inserting adeflated or collapsed cannula holder through the opening, thereafterinflating the holder to an at least partially expanded configuration sothat the holder seals the opening, and disposing a plurality of cannulasin the holder so that after inflating of the holder the cannulastraverse the holder and extend from outside the patient to inside thepatient. After inflating of the holder, a plurality of elongate medicalinstruments are inserted through respective ones of the cannulas.

Where the holder includes at least one passageway extending from anupper surface of the holder to a lower surface thereof, the disposing ofthe cannulas in the holder includes passing one of the cannulas throughthe passageway. The passing of the one cannula through the passageway inthe holder is preferably, but not necessarily performed after theinflating of the holder.

The inflating of the holder may be implemented by feeding a fluid suchas a saline solution or carbon dioxide gas through a one-way valve intothe holder.

The disposing of the cannulas in the holder generally includes couplingat least one of the cannulas to the holder after the inflating of theholder. Alternatively or additionally, at least one of the cannulas iscoupled to the holder prior to the inserting of the deflated orcollapsed holder through the opening in the patient. In any event, thecoupling may be accomplished by inserting the one cannula through apassageway in the holder. The passageway is preferably formed withflexible walls for sealing purposes. Alternatively, the passageway maybe rigid and provided with one or more valves exemplarily in the form ofa perforated resin web, which after insertion of laparoscopic instrumentwill prevent leakage of gas.

Where the cannula holder is substantially rigid or semirigid, thesurgical method in accordance with the present invention, comprisesforming an opening in a patient, inserting the cannula holder throughthe opening, and disposing a plurality of cannulas in the holder so thatafter inserting of the holder the cannulas traverse the holder andextend from outside the patient to inside the patient. After insertingof the holder, a plurality of elongate medical instruments are insertedthrough respective ones of the cannulas.

Pursuant to another feature of the present invention, an instrument andthe respective cannula have a C-shaped curve in a region traversing theholder after insertion of that instrument through the respectivecannulas.

A laparoscopic medical instrument in accordance with the presentinvention comprises an elongate shaft having an operative tip at one endand a manual actuator at an opposite end, with the shaft having apreformed inherently S-shaped configuration. The shaft may besubstantially rigid through or, alternatively, semi-rigid and flexibleso that the shaft may be deformed from the S-shaped configuration to astraightened configuration upon application of deformation forces to theshaft. In the latter case, the shaft is made of a material with a memoryso that the shaft automatically returns to the S-shaped configurationafter relaxation of deformation forces. In another alternative design,the shaft has a first curved C-shaped portion that is resilient andanother curved C-shaped portion that is rigid.

In another alternative design of a laparoscopic medical instrument inaccordance with the present invention, the shaft has a proximal rigidC-shaped portion and a distal flexible portion. The distal portion isflexed into substantially rigid C-shape by a mechanism, controlled by amanual actuator, so the instrument assumes a rigid S-form when needed bythe surgeon.

According to an exemplary embodiment of the present invention,laparoscopic instruments and trocar sleeves or cannulas are provided forperforming laparoscopic procedures entirely through the umbilicus.S-shape laparoscopic instruments, which are inserted into the generallyC-shaped or flexible cannulas markedly increase the work space betweenthe surgeon's hands as well as the manipulated laparoscopic instruments,particularly when the laparoscopic instrument-trocar units are placedthrough the umbilicus. In order to facilitate retraction ofintra-abdominal structures during a laparoscopic procedure, an angulatedneedle and thread with either one or two sharp ends is provided.Alternatively, an inflatable or substantially rigid unit having at leastone generally C-shaped trocar sleeve or cannula incorporated within theunit's walls can be placed through the umbilicus following a singleincision.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a conventional laparoscopic instrumentinserted through a conventional straight trocar sleeve or cannula.

FIG. 2A is a side view and FIG. 2B is an end view of an exemplaryembodiment of a flexible C-shaped trocar sleeve or cannula. FIG. 2C isan exemplary embodiment of an S-shaped instrument.

FIG. 3 is a schematic view of an exemplary embodiment of an S-shapedlaparoscopic instrument inserted through a C-shaped flexible trocarsleeve or cannula.

FIG. 4A is a lateral view and FIG. 4B is a perspective view of anexemplary inflatable unit with multiple C-shaped trocar sleeve orcannulas incorporated within the unit.

FIG. 5A is a non-inflated lateral view and FIG. 5B is an inflatedlateral view of an exemplary inflatable C-shaped trocar sleeve orcannula having a balloon-like structure within the hollow body of thecannula.

FIG. 6 is a lateral view of an exemplary angulated needle with two sharpends and a thread attached at the angle of the needle.

FIG. 7 is a lateral view of an exemplary angulated needle having a longsegment with a pointed end on one side of the angle and a short segmenthaving attached thread on the other side of the angle.

FIG. 8 is a cross-sectional view of an exemplary embodiment of aninflatable unit having multiple cannulas incorporated within the unit.

DETAILED DESCRIPTION

The present invention provides laparoscopic instruments and trocarsleeves or cannulas for the performance of laparoscopic proceduresentirely through the umbilicus. Referring now in specific detail to thedrawings, in which like reference numerals identify similar or identicalelements, there is shown in FIG. 1 a conventional, prior artlaparoscopic instrument-trocar assembly.

As illustrated in FIG. 1, a conventional trocar sleeve or cannula 1 isan essentially straight, hollow instrument, which allows conventionallaparoscopic instruments 3 such as an endoscope of suitable diameter tobe inserted through the conventional cannula 1 and into the abdominalcavity 5 of a patient. Conventional cannulas 1 have a diameter of around2-15 mm. Once the conventional laparoscopic instruments 3 are in place,standard laparoscopic procedures may be performed, such ascholecystectomy, appendectomy, or simple diagnostic laparoscopy.

As shown in FIG. 1, when conventional trocar sleeves or cannulas I andconventional laparoscopic instruments 3 are inserted only through theumbilicus of the patient, the close proximity of the instruments to eachother results in the so-called chopstick effect, which is a significantlimitation to the manipulation of conventional laparoscopic instruments3 through conventional trocars 1.

As shown in FIG. 2A and FIG. 2B, an exemplary C-shaped trocar sleeve orcannula 7 according to an embodiment of the present invention isgenerally an elongated tube having a proximal end 15 and a distal end17. In one exemplary embodiment the C-shape curve through ends 15, 17 isbent so that each end portion forms an angle of approximately 30° withrespect to a tangent to the center of the trocar sleeve or cannula 7.However, any angle, which sufficiently reduces the chopstick effect, maybe used. Thus, exemplary embodiments of the present invention withangles from 5-45° may be used. A C-shaped trocar sleeve or cannula 7 maybe made of conventional material as is known in the art. The interiordiameter of a C-shaped cannula 7 is preferably around 5 mm. However, inalternate embodiments the interior diameter of the C-shaped cannula 7may range from 2-15 mm. In one exemplary embodiment, the C-shape isrelatively fixed and does not vary, for example when the cannula 7 has arigid composition. In an alternate exemplary embodiment, the C-shapedcannula 7 is more flexible allowing the surgeon or surgical assistant tobend the cannula 7 changing the angle of the C-shape, for example, viainsertion of an instrument into the cannula.

In an alternative design, trocar sleeve or cannula 7 is made of aflexible material with a memory. Trocar sleeve 7 or cannula 7 may have astraight or linear cylindrical configuration in a relaxed state, i.e.,in the absence of externally applied forces. Sleeve or cannula 7 assumesthe curved or arcuate configuration shown in FIG. 2A upon the insertionthrough the cannula of a laparoscopic instrument shaft with a curved orarcuate section of sufficiently greater rigidity than the cannula.Cannula 7 then bends through the application of external forces to takethe arcuate form shown in FIG. 2A.

FIG. 2C illustrates an exemplary S-shaped laparoscopic instrument 10 inaccordance with an embodiment of the present invention. The S-shapedlaparoscopic instrument 10 has, for example, a shaft 10 a with apreformed inherently S-shaped configuration including a proximal curve20 and a distal curve 21. Examples of laparoscopic instruments 10 whichcan be formed generally into an S-shape according to an embodiment ofthe present invention include but are not limited to scissors, clamps,dissectors, staplers, clip appliers, retrieval bags, and electrocauteryinstruments. Instruments 10 include a manual actuator 10 b at a proximalend and an operative tip 10 c at a distal end. The S-shaped shaft 10 amay be substantially rigid throughout. Alternatively, shaft 10 a or aportion thereof, for example, distal curve 21, may be semi-rigid andflexible so that the shaft may be deformed from the S-shapedconfiguration to an at least partially straightened configuration uponapplication of deformation forces to the shaft. In the latter case, theshaft is made of a material with a memory so that the shaftautomatically returns to the S-shaped configuration after relaxation ofdeformation forces. In another alternative, proximal shaft portion 20 isrigid while distal shaft portion 21 is flexible. Distal portion 21 isflexed into substantially rigid C-shape by a locking mechanism (notseparately shown), controlled by actuator 10 b, so the instrumentassumes a rigid S-form when needed by the surgeon. In any event, theS-shape for these instruments can be achieved, for example, by usingconventional manufacturing techniques modified to accommodate theS-shape contour of the instrument.

As illustrated in FIG. 3, a generally S-shaped laparoscopic instrument10 may be S inserted through a C-shaped trocar sleeve or cannula 7. Forexample, the proximal curve 20 of the S-shaped instrument 10 correspondsto the curve of the C-shaped cannula 7. The distal curve 21 of theS-shaped instrument 10 also corresponds to the curve of the C-shapedcannula 7 and when inserted through the C-shaped cannula 7 will be, forexample, entirely within the abdominal cavity 5 of the patient. Anembodiment of the present invention, for example, a C-shaped cannula 7and S-shaped laparoscopic instrument 10 allows the surgeon to performthe laparoscopic procedure without making incisions outside of theumbilicus. In accordance with the present invention, the size andcurvature of a C-shaped cannula 7 will correspond to the size andcurvature of an S-shaped instrument 10 and can include any desired size.

This arrangement of C-shaped cannula 7 and S-shaped instrument 10eliminates the “chopstick effect” which results from the insertion ofconventional laparoscopic instruments 3 through the umbilicus. Forexample, the proximal curves of the S-shaped instruments 10 and theC-shaped cannula 7 allows the surgeon's hands and the proximal portionsof the instruments 20, including the instruments' handles, to be placedas far apart as is convenient for the surgeon. For example, workspace 9a is created. Movement of the proximal portion of one instrument 20 awayfrom the proximal portion 20 of the other also markedly separates theexposed (e.g. outside the body cavity) shafts of each instrument. Thedistal curve of the S-shaped instrument 21 creates workspace 9 b betweenthe portions of the instruments in the abdominal cavity and redirectsthe distal end of the laparoscopic instrument 10 back toward a targetsite 8, such as an abdominal organ or other abdominal structure or site.

Thus, an S-shaped laparoscopic instrument 10 may be thought of as havingfour segments or sections to allow an abdominal procedure to beperformed entirely through theumbilicus and yet overcome the “chopstickeffect” encountered with conventional laparoscopic: instruments 3 andcannulas 1. First, the portion outside of the patient's abdominal cavity5 allows sufficient space between the surgeon's hands when manipulatingthe proximal portion of the laparoscopic instruments 10. Second, theportion at or near the umbilicus, which allows a laparoscopic instrument10 to enter the abdominal cavity 5 is in close proximity to one or moreadditional laparoscopic instruments 10 so that all instruments 10 enterthe abdomen through the umbilicus. Third, the portion beyond the secondportion, which creates separation between laparoscopic instruments 10within the abdominal cavity 5. Fourth, the distal end of a laparoscopicinstrument 10 is shaped to point back toward the target abdominal organ,tissue, or other site.

Examples of procedures which can be facilitated by the use of C-shapedtrocar sleeves or cannulas 7 and S-shaped laparoscopic instruments 10include, but are not limited to diagnostic laparoscopy, cholecystectomy,appendectomy, ovaro-hysterectomy, removal of a section of bowel, avariety of gastric procedures, biopsy of various abdominal organsincluding the liver, laparoscopic staging for cancer, and hernia repair.

The following discussion describes, as an example, a cholecystectomyprocedure according to an embodiment of the present invention asdescribed in FIGS. 2A-C and FIG. 3. It should be noted, however, thatmany other laparoscopic procedures may be performed using variousembodiments of applicant's invention. The following description,therefore, is merely illustrative and is not intended to limit thepresent invention to the description given in this example.

A laparoscopic procedure, such as a cholecystectomy, using a curvedC-shaped flexible or rigid trocar sleeve or cannula 7 and S-shapedlaparoscopic instruments 10 of the present invention is performed withthe patient under general anesthesia. Carbon dioxide gas is insufflatedintra-abdominally to 15 mm Hg through a 5 mm lateral umbilical incisionusing, for example, a VERESS™ needle. For example, two curved C-shaped 5mm cannulas 7 are then inserted through an incision in the umbilicus.The surgeon operates, for example, a 5 mm endoscope with one hand and a5 mm S-shaped laparoscopic instrument 10 with the other, each of whichare passed through is a respective cannula 7. The cannula for theendoscope could be straight so that a conventional straight endoscopecould be used, the other curved cannula 7 providing separation betweenthe instruments and the surgeon's hands. Pericholecystic adhesions, ifpresent, are removed by blunt or sharp dissection using an S-shapeddissector to expose the dome of the gallbladder. A 2-0 nylon (or othersuitable material) stay suture on a needle is placed through theabdominal wall immediately below the right costal margin at the rightanterior axillary line, allowing for superior retraction of the gallbladder dome. The removal of the adhesions from around the gallbladderinfundibulum is then continued as necessary. A second stay suture isplaced through the right flank and then through the neck of thegallbladder allowing for lateral retraction to expose the cysticstructures. The cystic duct and cystic artery are dissected, thenligated with clips, utilizing a 5 mm S-shaped clip applier, and thenfinally transected with an S-shaped scissors. With continued retractionfrom stay sutures, the gallbladder is removed from the liver bedutilizing an S-shaped electrocautery device equipped with a hook,dissecting the gallbladder from medial to lateral and inferior tosuperior direction. The perihepatic area is then irrigated using anS-shaped irrigation/suction device.

The above-described procedure is greatly facilitated by the use ofS-shaped laparoscopic instruments 10 and C-shaped cannulas 7, allowingthe procedure to be performed entirely through the umbilicus while atthe same time reducing or eliminating the “chopstick effect”. Forexample, each of the S-shaped laparoscopic instruments is inserted andremoved from the active curved cannula 7 as needed during the procedureand conflict with the endoscope is avoided. Thus, as a result, improvedcosmesis, reduced operative and post-operative complications, and a lesscomplicated surgical technique are achieved.

FIG. 4A and FIG. 4B illustrate an inflatable cannula holder 30 having,for example, multiple C-shaped trocar sleeves or cannulas incorporatedwithin the unit 30. The lateral wall 34 of the inflatable cannula holderunit 30 may vary from extremely flexible 20 and stretchable whendeflated, thus facilitating insertion into the umbilical incision, tosomewhat rigid when inflated during the surgical procedure. Theinflatable unit 30 has, for example, a horizontal upper plate 31 and ahorizontal lower plate 32. Curved or arcuate trocar sleeves or cannulas33 a, 33 b, and 33 c will extend through the horizontal upper plate 31and horizontal lower plate 32 and may be incorporated within the lateralwall 34. Cannulas 33 a, 33 b, 33 c may be rigid or flexible members. Oneor more straight trocar sleeves or cannulas 33 d may also be providedwhich traverse holder unit 30 and particularly upper surface 31 andlower surface 32 thereof. Any given straight cannula 33 d may be rigidor flexible. In the latter case, the cannula 33 d may be sufficientlyflexible to bend in conformation to a generally C-shaped section 20 or21 (FIG. 2C) of laparoscopic instrument 10. Shaft 10 a or section 20, 21thereof is either rigid or has a sufficient rigidity to force thebending of cannula 33 d. One or more of cannulas 33 a, 33 b, and 33 cmay similarly be flexible members with a memory tending to return thecannulas to a straight or arcuate configuration.

Rigid sections 311 may be inserted or attached around the periphery ofthe horizontal upper 31 or lower 32 plate to add stability. Thehorizontal upper plate 31 and horizontal lower plate 32 may be, forexample concave or straight. At least one and possibly two or moreC-shaped trocar sleeves or cannulas 33 a, 33 b, 33 c, (describedpreviously) can be incorporated within the lateral wall 34 of theinflatable unit 30 and are distributed, for example, evenly around thewall 34 of the unit 30. The upper 31 and lower plate 32 are preferablymade of a flexible plastic material or other suitable surgical qualitymaterial.

In an alternate embodiment, the inflatable unit 30 has one or moreC-shaped trocar sleeves or cannulas 7 incorporated within its lateralwall 34, and one or more straight cannula 1, also incorporated withinthe inflatable unit's lateral wall 34. The straight cannula mayaccommodate, for example, a straight endoscopic or laparoscopicinstrument, while the C-shaped cannulas 7 can accommodate an S-shapedinstrument 10 as described above. Thus, even where one of theinstruments is relatively straight and passes through a relativelystraight cannula 1, the chopstick effect is still reduced as a result ofthe remaining C-shaped cannulas 7 and S-shaped instruments 10, whichprovide space between the surgeons hands, the proximal portions oflaparoscopic instruments (which includes the straight laparoscope), andthe distal ends of the laparoscopic instruments (which also includes thestraight laparoscope).

Inflatable unit 30 may include one or more passageways 40 a and 40 dformed by generally cylindrical webs of resilient material (notseparately designated) connected at opposite ends to upper surface 31and lower surface 32. Upon inflation of unit 30, the webs close thepassageways and, upon insertion of respective cannulas 33 a and 33 d,form a sealed engagement therewith. In one possible mode of use,cannulas 33 a and 33 d are inserted through passageways 40 a and 40 donly after placement of unit 30 in an opening formed in a patient andupon inflation of the unit. Alternatively, all cannulas 33 a, 33 b, 33c, 33 d may be disposed within and coupled to unit 30 prior to thepositioning thereof in the patient.

The surgeon may place the inflatable unit 30 through an approximately1.5 to 2.5 cm incision in the umbilicus. The unit 30 is inserted priorto inflation with the C-shaped cannulas 33 a, 33 b, 33 c, for example,parallel and in close proximity to each other. The upper plate 31 willremain outside of the umbilicus while the lower plate 32 is located justinside the abdominal cavity 5. Once the unit 30 is properly positioned,the surgeon or assistant may inflate the unit 30. The unit 30 may beinflated via, for example, a one-directional valve using a syringe orgas line inserted into a narrow hollow tube connected to the unit 30 asis known in the art. The syringe or gas line may be alternativelyinserted directly into a one-directional valve. Thus, means forinflating the unit 30 can be similar to the means for inflating aconventional endotracheal tube.

In an exemplary embodiment, the diameter of the inflatable unit 30increases upon inflation. The unit may be inflated to the extent neededfor the particular laparoscopic procedure. By placing the trocar sleevesor cannulas in the lateral walls of the inflatable unit, the surgeon mayposition a trocar sleeves or cannula, and thus an instrument insertedthrough a cannula, as far away from the other cannulas and instrumentsas possible within the confines of a chosen space such as the umbilicus.In addition, the surgeon may change the position of the cannulas andinstruments within the umbilicus by rotating the inflatable unit 30around its vertical axis. This change of position of the cannulas allowsintra-operative adjustments of the position of an instrument as well asthe type of instrument to further facilitate the intra-abdominalprocedure. Moreover, the inflatable unit 30 seals the opening of thepatient's abdominal cavity 5 to prevent leakage of CO₂ as a result ofthe inflation.

An additional cannula 42 may be disposed outside of the holder 30 andspaced from holder outer wall 34. A connector 44 in the form of a web ortube couples cannula 42 to cannula holder 30.

In an alternate embodiment as shown in FIG. 8, the distance between theupper plate 31 and the lower plate 32 may be reduced, thereby increasingthe ability of the trocar sleeve or cannula 7 to move in relation to thewall of the inflatable unit 30. In addition, reducing the distancebetween the upper plate 31 and lower plate 32 allows the size of thetrocar sleeves or cannulas incorporated within the unit 30 to bereduced, which further enhances the ability of the cannula to move inrelation to the wall of the inflatable unit 30. In one exemplaryembodiment, the cannula is immediately adjacent to the lateral wall 34.In another exemplary embodiment the cannula is not immediately adjacentto the lateral wall 34, but is separated by an additional connector 91to provide even greater flexibility.

Thus, as an example, the cholecystectomy procedure described above maybe performed using the inflatable unit 30 in conjunction with S-shapedlaparoscopic instruments 10, rather than using separatecannula/instrument arrangements. Once the gallbladder is transected andremoved from the liver bed, it is removed through the 1.5 to 2.5 mmincision along with the inflatable unit 30. If necessary, the initialincision can be extended to remove an enlarged gallbladder.Alternatively, the gallbladder may be opened to remove or crush materialpresent in the gallbladder such as gallstones, facilitating removal ofthe gallbladder and the inflatable unit 30 through the umbilicalincision.

As shown in FIG. 5A and FIG. 5B, an alternate exemplary embodiment ofthe present invention provides an inflatable unit 70 including a singleC-shaped trocar sleeve or cannula 7 having a radially expandable andinflatable balloon-like structure 75 incorporated within the hollowlumen 73 of the cannula. A single laparoscopic instrument may beinserted within this inflatable unit 70. This unit 70 may then beinflated to secure the cannula and laparoscopic instrument together asone movable unit. The inflatable unit 70 may be inflated via, forexample, a one-directional valve using a syringe or gas line insertedinto a narrow hollow tube 74 connected to the unit 70 as is known in theart. The syringe or gas line may be alternatively inserted directly intoa one-directional valve. Thus, means for inflating the unit 70 can besimilar to the means for inflating a conventional endotracheal tube.Inflating the inflatable unit 70 also serves to seal the abdomenpreventing insufflated gas from escaping through the lumen of thecannula. The inflatable unit 70 then may be deflated, the laparoscopicinstrument may be removed, and a different instrument may be inserted.

While the above description of S-shaped instruments 10 and C-shapedcannulas 7 has been directed to procedures performed entirely throughthe umbilicus, it is to be understood that embodiments of the presentinvention may be adapted for use in other entry sites. Therefore, whenit is desirable to have entry of multiple instruments in a relativelylocalized area, embodiments of the present invention may be used forsuch entry, while reducing or eliminating the so-called “chopstickeffect”. Thus, existing scars or hidden areas such as the pubic hairline or the axillary region may be used as a localized entry site.Procedures such as repair of a ventral hernia may be performed using anon-umbilical localized entry site.

As illustrated in FIG. 6, an angulated bi-directional needle 50 inaccordance with the present invention is provided with a first sharp end51, a second sharp end 52, and a surgical thread 55 attached to theangle 57 of the needle 50. The needle 50 has, for example, a totallength of around 5-10 cm. The length of each segment from angle to sharpend is roughly equivalent, but need not be. An acute angle of around160° is formed by the angulated needle 50, however angles 57 rangingfrom a straight needle, i.e. 180°, to an acute angle 57 of around 90°may be used. The needle is formed out of steel or other suitablematerial. The surgical thread 55, such as 2-0 nylon, is attached at theangle 57 of the needle 50.

The angulated needle 50 according to an embodiment of the presentinvention simplifies suture delivery through the gall bladder or otherabdominal structure. For example, the first sharp end 51 of the needle50 is inserted through the body wall by the surgeon. The needle 50 isthen grasped within the abdominal cavity 5 by a laparoscopic instrumentunder endoscopic guidance and is pulled toward the organ of interest.With the second sharp end 52 leading, a stitch is placed through theabdominal structure of interest. The second sharp end 52 is thendelivered through the abdominal wall.

The angulated bi-directional needle 50 allows delivery of a stitchwithout changing the orientation of the sharp end as would be necessaryif a needle with only one sharp end is used. Changing orientation of aneedle with only one sharp end is a somewhat complicated task requiringadvanced laparoscopic skills and may result in iatrogenic injury.

An alternative exemplary embodiment of an angulated needle is shown inFIG. 7. In this embodiment the angulated needle 60 has, for example, along segment 61 with one sharp end 62 on one side of the angle 65. Theneedle 60 has a blunt short segment 67 on the other side of the angle65. Thread 68 is attached to the end of the blunt short segment 67.

The angulated needle 60 allows penetration through the body wall as astraight needle. The needle 60 is inserted into and through the wall ofthe gallbladder. The needle is then flipped 180° and delivered backthrough the abdominal wall. The angulated needle 60, can be used toreposition a gall bladder or other structure during a laparoscopicprocedure by, for example, pulling or relaxing the suture, whicheliminates or reduces the need for the insertion of one or moreadditional cannulas and laparoscopic instruments for that purpose. Theangulation of the angulated needle 60 also reduces the chance ofiatrogenic injury to surrounding structures by allowing the needle 60 tobe flipped and then delivered back through the abdominal wall prior tocontacting surrounding abdominal structures.

While several exemplary embodiments of laparoscopic instruments andcannulas for the performance of laparoscopic procedures entirely throughthe umbilicus have been described herein, it is to be understood thatvariations may be made in the laparoscopic instruments and cannulaswithout departing from the spirit and scope of the present invention asdefined by the appended claims.

What is claimed is:
 1. A trocar holder for holding multiple spaced-aparttrocars comprising: an upper plate; a separate lower plate spaced fromand disposed below the upper plate; and an outer wall connected betweenthe upper plate and the lower plate, the outer wall defining a cavity, aflexible distal portion of which forms a portion of the surgical site,multiple spaced apart passageways independent of the outer wall anddefined through the upper plate and the lower plate that are configuredto enable multiple trocars to be disposed through the upper plate, andwherein at least one of the multiple trocars has a straightconfiguration, wherein the upper and lower plates are configured suchthat the multiple trocars can move in relation to the outer wall, andwherein the multiple trocars each have a proximal portion and a distalportion and wherein the proximal portion extends proximally of the upperplate.
 2. The trocar holder as in claim 1, wherein the at least onepassageway is formed by resilient material.
 3. The trocar holder as inclaim 1, wherein the outer wall is configured and dimensioned to bepositioned at least partially within a surgical incision in a subject.4. The trocar holder as in claim 3, wherein the lower plate cooperateswith the outer wall to seal the upper plate in position with respect toa surgical incision in the subject.
 5. The trocar holder as in claim 4,wherein the upper plate, the outer wall and the lower plate togetherdefine a working access for surgical instruments positioned in themultiple trocars.
 6. The trocar holder as in claim 5, wherein at leastthe outer wall is deformable between a first position for insertion intoa surgical incision and a second position in sealing contact with thesurgical incision.
 7. The trocar holder as in claim 1, wherein thetrocar holder is configured such that the multiple trocars define spacedapart trocars and the at least one passageway enables the spaced apartmultiple trocars to be inserted into the at least one passageway priorto insertion of the lower plate in a surgical incision of a subject. 8.The trocar holder as in claim 7, wherein the trocar holder is configuredsuch that the at least one passageway enables the spaced apart multipletrocars to be inserted into the at least one passageway after insertionof the lower plate in a surgical incision of a subject.
 9. A trocarholder for holding multiple spaced-apart trocars comprising: a flexiblesleeve defining a portion of a surgical site, the flexible sleeve havinga proximal portion and an open distal portion defining a cavity therein,the distal portion forming the portion of the surgical site; an upperplate; a separate lower plate spaced from and disposed below the upperplate; and an outer wall connected between the upper plate and the lowerplate, at least one passageway defined by the upper plate, the lowerplate and the outer wall, the trocar holder upper plate having multiplespaced-apart openings configured to enable multiple trocars to bedisposed through the upper plate, wherein at least one of the trocarshas a straight configuration, and wherein the at least one of thetrocars having a straight configuration is at least partially disposed,at the upper plate, through the at least one passageway, wherein theupper and lower plates are configured such that the trocars can move inrelation to the outer wall, and wherein the trocars each have a proximalportion and a distal portion and wherein the proximal portion extendsproximally of the upper plate.
 10. The trocar holder as in claim 9,wherein the at least one passageway is formed by resilient material. 11.The trocar holder as in claim 10, wherein the at least one passagewayextends from the upper plate to the lower plate.
 12. The trocar holderas in claim 9, wherein the outer wall is configured and dimensioned tobe positioned within a surgical incision in a subject.
 13. The trocarholder as in claim 12, wherein the lower plate cooperates with the outerwall to seal the upper plate in position with respect to the surgicalincision in the subject.